Senior Manufacturing Science & Technology Specialist
Your tasks and responsibilities
The primary responsibilities of this role, Senior Manufacturing Science and Technology Specialist, are to:
- The incumbent is responsible for process development, scale-up, technology transfer, establishing and optimizing commercial manufacturing processes for compounding and filling of solids, soft- chews, non-sterile liquids and sterile injectable (aseptic manufacturing) platforms, working closely with Manufacturing, Engineering, and Quality organizations. Leading the development/engineering studies and batches and generating technical protocols, reports, manufacturing documentations and performing risk based assessments to detect quality and technological risks;
- Manages and controls the development of each project’s work scope and schedules required for the support of key product integrations, ensuring they are completed on budget, on schedule, and technically correct;
- Identify critical quality attributes and the strategy for defining acceptable ranges for process parameters. Understands the product and process complexity and supports Validation and Quality in establishing the testing/characterization requirements for various process steps and overall manufacturing process validation;
- Develops an understanding of product stability (physical and chemical) to guide design of studies in support of product registration and regulatory submissions;
- Serve as single point of contact for internal teams and external customers as transfer lead for all product transfers. Provide proper levels of customer service, but ensuring Bayer’s interests are maintained. Act as key interface with internal and external resources as needed to facilitate the transfer of process knowledge to the manufacturing environment;
- Lead Project Team that includes: a project team of internal and external staff in support of Product Transfers;
- Lead assessments regarding timelines, technical viability, resources, financial, investments, and communications needed to support product transfer activities;
- Support MFG efficiency and operations projects by interfacing with all internal departments (Quality Assurance, Engineering, Information Technology, Validation, Manufacturing, Planning, and Supply Chain Management). Troubleshoot challenges associated with process technology;
- Interact with regulatory agencies during audits and process reviews
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Bachelor’s Degree in Industrial Pharmacy, Pharmaceutics, Chemical Engineering or scientific field with minimum of five years of industry experience OR Master’s Degree with minimum of three years of experience;
- The candidate must have familiarity with processing equipment and technologies utilized in Good Manufacturing Practices(GMP) manufacturing facilities for solids, soft- chews, non-sterile liquids or injectable platforms (at least in 1 areas).
- A good understanding of Current Good Manufacturing Practices (cGMP) compliance requirements;
- Experience in leading technical cross-functional teams or relevant technical project management experience;
- The ability to lead, manage, motivate, and direct professional technical personnel relative to changing priorities, sense of urgency, and utilization of multiple skill sets;
- The incumbent must demonstrate high levels of value and integrity. They must instill company visions, values and beliefs in others by example;
- A thorough knowledge of current pharmaceutical technology, project implementation practices and the ability to analyze problems is necessary in order to effectively direct the activities of his/her project team;
- Ability to prepare technical documents;
- Strong communication skills and computer literacy.
- Process Technology Development experience preferrably in product transfers and optimization.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Location: KS-Shawnee Mission
Functional Area: [sap_fa_2]
Entry Level: 5